ABSTRACT ? PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) for the Tisch Cancer Institute (TCI) oversees all cancer related clinical research at Mount Sinai in order to ensure that it is of the highest scientific merit and that TCI resources are used efficiently. The PRMS consists of the Protocol Review and Monitoring Committee (PRMC) and the Scientific Progress and Accrual Review Committee (SPARC), a subcommittee of the PRMC. The PRMC review process ensures that all research is safe and scientifically sound with entry criteria that reflect our patient population, have a high probability of full accrual, do not compete with each other, have adequate resources to answer the question being asked, and is consistent with the priorities of the TCI. The SPARC review process monitors active protocols for continued scientific merit, progress, and accrual. Pre-PRMS evaluations are completed by the Disease Focus Groups (DFG) and the Data Safety and Monitoring Committee (DSMC). If applicable, protocols also receive a Resource Allocation Evaluation (RAE). The outcome from each of these evaluations is submitted to the PRMC for reference, ensuring that each protocol receives a thorough, high quality peer review. The PRMC review occurs prior to the submission to the Institutional Review Board (IRB). PRMS functions are independent of the IRB, and do not duplicate or overlap with the responsibilities of the IRB. The PRMS has the authority to open protocols that meet the scientific merit and priorities of the TCI and to terminate protocols that do not demonstrate scientific progress.